MAUDE Adverse Event Report: OSTEOMED, LLC SERIES II LOW PROFILE MODULAR MOTOR UNIT

Model Number	450-0084
Medical Device Problem Codes	Mechanical Problem (1384); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is on going and a supplemental report will be submitted on completion of investigation.
Event or Problem Description
On october 26, 2021, the customer contacted osteomed product manager by email.Per the email: "the console unit will spontaneously begin running on reverse, without anyone pressing the foot pedal! " the involved part numbers are as follows: complaint #, part #, description, serial #; (b)(4), 450-0084, series ii low profile modular motor unit, (b)(4); (b)(4), 450-0021, power control console 2 (b)(4); (b)(4), 450-0390, bmf footswitch (b)(4).
Additional Manufacturer Narrative
H6: type of investigation, investigation findings, and investigation conclusion updated to reflect device evaluation.The device was returned for evaluation.No issue was found with the device, and the device passed all tests.This report is related to report number 2027754-2021-00022 for the power console and 2027754-2021-00023 for the footswitch.The dhr was reviewed for the reported lot number and all inspections passed per the dhr.
Additional Manufacturer Narrative
The investigation is on going and a supplemental report will be submitted on completion of investigation.
Event or Problem Description
On october 26, 2021, the customer contacted osteomed product manager by email.Per the email: "the console unit will spontaneously begin running on reverse, without anyone pressing the foot pedal! " the involved part numbers are as follows: complaint #, part #, description, serial #; (b)(4), 450-0084, series ii low profile modular motor unit, (b)(4); (b)(4), 450-0021, power control console 2 (b)(4); (b)(4), 450-0390, bmf footswitch (b)(4).

• Brand Name: SERIES II LOW PROFILE MODULAR MOTOR UNIT
• Common Device Name: SERIES II LOW PROFILE MODULAR MOTOR UNIT
• Manufacturer (Section D): OSTEOMED, LLC; 3885 arapaho rd.; addison TX 75001
• Manufacturer (Section G): OSTEOMED, LLC; 3885 arapaho rd; addison TX 75001
• Manufacturer Contact: flor rivera ; 3885 arapaho rd.; addison, TX 75001 ; 9726774600
• MDR Report Key: 12820520
• Report Number: 2027754-2021-00021
• Device Sequence Number: 5737050
• Product Code: GBB
• UDI-Device Identifier: 00845694012263
• UDI-Public: 00845694012263
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: 971692
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 450-0084
• Device Catalogue Number: 450-0084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2021
• Supplement Date Received by Manufacturer: 03/21/2022
• Initial Report FDA Received Date: 11/16/2021
• Supplement Report FDA Received Date: 03/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown